Unique ID issued by UMIN | UMIN000026375 |
---|---|
Receipt number | R000030310 |
Scientific Title | Observation study of the relationship between intestinal bacterial flora and therapeutic effect or adverse events on advanced non-small cell lung cancer patients treated with nivolumab. |
Date of disclosure of the study information | 2017/03/02 |
Last modified on | 2021/06/28 16:44:57 |
Observation study of the relationship between intestinal bacterial flora and therapeutic effect or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.
Observation study of the relationship between bacterial flora and effect or AEs on NSCLC patients treated with nivolumab.
Observation study of the relationship between intestinal bacterial flora and therapeutic effect or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.
Observation study of the relationship between bacterial flora and effect or AEs on NSCLC patients treated with nivolumab.
Japan |
Non-Small-Cell Lung Cancer
Pneumology |
Malignancy
NO
To evaluate the relationship between intestinal bacterial flora and therapeutic effect or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.
Others
Relationship between intestinal bacterial flora and therapeutic effect of nivolumab.
Others
Others
Not applicable
Relationship between intestinal bacterial flora and therapeutic effect of nivolumab.
Relationship between variation of bacterial flora and therapeutic effect, AEs or PD-L1 expression.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1)Histologically or cytologically proven non-small cell lung cancer
2)Pretreated NSCLC, without immune chekpoint inhibitor
3)ECOG PS : 0-2
4)When taking lactobacillus preparation (including marketing medicines), it can be canceled from one week before registration to the end of observation period.
5)At least one measurable lesion by RECIST
6)Life expectancy more than 12 weeks.
7)Written informed consent.
8)Patients who have had the following administration periods from the previous treatment
A.chemotherapy:Not specified
B.radiation
chest: >4weeks
Other than chest: >2 weeks
C.surgery
major: >4weeks
minor: >2weeks
1)With active or history of Interstitial pneumonia.
2)Interstitial change or pulmonary fibrosis detectable on X ray
3)Autoimmune disease.
4)Patients receiving corticosteroids (up to 10 mg/day in terms of prednisolone is acceptable) or immunosuppressants within 2 weeks before registration.
5)Patients receiving antibiotics within 5 weeks before registration
6)Patients who are pregnant or nursing
7)With active or history of inflammatory bowel disease.
8)Evaluated to be ineligible by a physician for other reasons.
30
1st name | TAKASHI |
Middle name | |
Last name | YOKOI |
Hyogo College of Medicine
Department of Thoracic Oncology
663-8501
1-1, Mukogawa-cho, Nishinomiya, Hyogo
0798-45-6596
ta-yokoi@hyo-med.ac.jp
1st name | RYO |
Middle name | |
Last name | ITOTANI |
Kitano Hospital
Respiratory medicine
530-8480
2-4-20, Ogimachi, Kita-ku, Osaka-city
06-6312-1221
itotani@kitano-hp.or.jp
Kansai Clinical Oncology Group
ONO PHARMACEUTICAL CO., LTD.
Bristol-Myers Squibb
Profit organization
The Ethics Review Board of Hyogo College of Medicine
1-1, Mukogawa-cho, Nishinomiya, Hyogo
0798-45-6111
rinri@hyo-med.ac.jp
NO
兵庫医科大学病院、関西医科大学附属病院、北野病院
2017 | Year | 03 | Month | 02 | Day |
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_view.cgi?recptno=R000030310
Unpublished
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000030310
32
・Primary
1. Relationship between DCR and gut microbiota. : No significant difference was observed in all bacterial species.
2. Relationship between ORR and gut microbiota.:
Clostridium subcluster XIVa showed a significant correlation (HR:1.146, 95% C.I.:1.025-1.282, p=0.0165). But no significant difference was found in other species.
・Secondary
Relationship between ORR and changes in gut microbiota.: No significant difference was observed in all bacterial species.
2021 | Year | 06 | Month | 28 | Day |
Delay expected |
Result analysis and treatise writing are delayed.
Patient characteristics of 27 patients whose consent was obtained and whose stool samples could be collected and analyzed.
Median age: 70 years (46-88)
Gender: 25 males, 2 females
Stage: III 8 cases, IV 13 cases, postoperative recurrence 6 cases
Smoking history: 25 smoker, 2 non-smoker
Gene mutation: Yes 3 cases, No 20 cases, Unknown 4 cases
This study is multicenter observational study to evaluate the relationship between gut bacterial flora and therapeutic effects and/or adverse events in advanced non-small cell lung cancer patients treated with nivolumab.
Fatigue; Grede1: 5 cases (15.6%)
ILD; Grade 1: 3 cases (8.6%), Grade 3: 1 case (2.9%)
Hypothyroidism; Grade 1: 5 cases (15.6%), Grade 2: 1 case (2.9%)
Rash; Grade 1: 4 cases (11.4%)
Stomatitis; Grade1: 1 case (2.9%)
Diarrhea; Grade 1: 1 case (2.9%)
Liver damage; Grade 3: 1 case (2.9%)
Constipation; Grade 1: 1 case (2.9%), Grade 2: 1 case (2.9%)
Acute exacerbation of COPD; Grade 3: 1 case (2.9%)
Primary objectives;
To evaluate the relationship between intestinal gut bacterial flora and therapeutic effect and/or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.
Secondary objectives;
To evaluate the relationship between the alteration of gut bacterial flora and therapeutic effects and/or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.
Enrolling by invitation
2017 | Year | 01 | Month | 21 | Day |
2017 | Year | 09 | Month | 08 | Day |
2017 | Year | 03 | Month | 02 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
Relationship between intestinal bacterial flora and therapeutic effect of nivolumab.
2017 | Year | 03 | Month | 02 | Day |
2021 | Year | 06 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030310
Research Plan | |
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Registered date | File name |
2021/06/16 | KCOG1615研究計画書v3.1.pdf |
Research case data specifications | |
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Registered date | File name |
Research case data | |
---|---|
Registered date | File name |
2019/04/22 | 20190422.xlsx |